Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment

Phase III, National, Multicenter, Randomized, Double-blind, Double-Masked, Compare the Efficacy of Ketoprofen + Cyclobenzaprine Association Versus Cyclobenzaprine (Miosan®) in the Treatment of Osteomuscular Pain in Adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03025113

Enrollment

416

Registered

2017-01-19

Start date

2018-03-08

Completion date

2020-03-27

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Pain

Brief summary

The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.

Detailed description

* Double-blind, randomized, multicenter * Maximal experiment duration: 9 days * 02 or 03 visits and a phone contact * Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults. * Adverse events evaluation

Interventions

DRUGketoprofen and cyclobenzaprine association

The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.

DRUGCyclobenzaprine

The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

IInclusion Criteria: * Signed Consent of the patient; * Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.

Exclusion criteria

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; * Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * Patients with history of hypersensitivity to any of the formula compounds; * Participation in clinical trial in the year prior to this study; * Pregnancy or risk of pregnancy and lactating patients; * Patients who were in use of drugs that can interfere with evaluation; * History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis; * Renal or hepatic impairment.

Design outcomes

Primary

Measure	Time frame
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.	48 hours

Secondary

Measure	Time frame
Safety will be evaluated by the adverse events occurrences	Maximal experiment duration: 9 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026